At a Glance
- Tasks: Lead quality initiatives for innovative diagnostic products and ensure compliance with global standards.
- Company: Join GE HealthCare, a leader in medical technology and innovation.
- Benefits: Competitive salary, flexible work environment, and opportunities for career growth.
- Other info: Dynamic role with global travel opportunities and a commitment to inclusion and diversity.
- Why this job: Make a real impact in healthcare by ensuring the quality of life-saving products.
- Qualifications: Bachelor's degree in a relevant field and strong QA experience in regulated environments.
The predicted salary is between 60000 - 75000 £ per year.
As QA Manager – New Product Implementation at GE Health Care, you will provide quality leadership for the development of innovative diagnostic radiopharmaceutical products and associated clinical manufacturing activities.
You will serve as the primary Quality representative for assigned development programs, providing strategic quality guidance throughout product development, technology transfer, and clinical supply activities.
Working closely with R&D, Regulatory Affairs, Technical Operations, Clinical Operations, and external manufacturing partners, you will ensure compliance with global GMP requirements, regulatory expectations, and GE Health Care Quality Management System requirements.
Responsibilities
- Serve as the Quality representative and partner for assigned R&D and clinical development programs.
- Provide QA oversight for product development, technology transfer, and clinical manufacturing activities.
- Lead quality support activities associated with qualification and onboarding of Contract Manufacturing Organizations (CMOs).
- Review and approve GMP and quality documents, including protocols, reports, investigations, deviations, CAPAs, change controls, and quality agreements.
- Support manufacture and release activities for investigational medicinal products (IMPs) used in clinical studies.
- Partner with cross-functional teams to ensure quality requirements are effectively incorporated throughout the product development lifecycle.
- Facilitate and participate in quality risk assessments.
- Lead or support investigations, root cause analyses, and CAPA activities.
- Support supplier audits, internal audits, client audits, and regulatory inspections.
- Monitor quality metrics and identify opportunities for continuous improvement.
- Participate in governance meetings with CMOs and development partners.
- Provide guidance and coaching to project teams on GMP requirements and quality systems.
- Support continuous improvement of R&D Quality processes and systems.
- Required Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Life Sciences, or a related scientific discipline.
- Strong experience within Quality Assurance in a GMP‑regulated pharmaceutical, biotechnology, or radiopharmaceutical environment.
- Experience supporting product development, technology transfer, clinical manufacturing, validation, or external manufacturing operations.
- Strong knowledge of GMP regulations, ICH guidelines, quality risk management, and pharmaceutical quality systems.
- Experience working with CMOs.
- Demonstrated ability to lead complex quality initiatives in a matrix environment.
- Experience supporting audits, inspections, investigations, CAPAs, and change controls.
- Strong communication, influencing, and stakeholder management skills.
- Preferred Qualifications
- Experience with radiopharmaceuticals, sterile manufacturing, or aseptic processing.
- Lead Auditor qualification or equivalent quality certification.
- Experience supporting global clinical development programs.
- Experience interacting with FDA, EMA, MHRA, or other health authorities.
- Additional Information
This role requires approximately 10–20% global travel to support technology transfer activities, external manufacturing oversight, audits, inspections, and project-related meetings.
- Relocation Assistance Provided: No
- Inclusion And Diversity
GE Health Care is an Equal Opportunity Employer where inclusion matters.
Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviours
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world‑changing realities.
Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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QA Manager - New Product Introduction in Chalfont St Giles employer: GE Healthcare
As a leading player in the pharmaceutical industry, we pride ourselves on fostering a collaborative and innovative work environment that empowers our employees to excel. Our commitment to professional development is evident through comprehensive training programs and opportunities for career advancement, ensuring that our Sr. Drug Safety Specialists are equipped with the skills needed to thrive in their roles. Located in a vibrant area, we offer a supportive culture that values teamwork and encourages meaningful contributions to global health.
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We think this is how you could land QA Manager - New Product Introduction in Chalfont St Giles
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like GE Healthcare.
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We think you need these skills to ace QA Manager - New Product Introduction in Chalfont St Giles
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at GE Healthcare!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show GE Healthcare that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at GE Healthcare!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At GE Healthcare, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at GE Healthcare
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at GE Healthcare that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with GE Healthcare’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
